Methods and devices for passing sutures around anatomical structures

ABSTRACT

Various exemplary methods and devices are provided for passing sutures around anatomical structures. In an exemplary embodiment, a suture delivery device is provided that includes a body portion having a suture delivery member disposed therein and configured to pass a suture around an anatomical structure. The suture delivery member can be movable between a retracted configuration in which the suture delivery member is disposed within the body portion and an advanced configuration in which the suture delivery member extends distally beyond the body portion and assumes an arcurate shape. The arcurate shape can correspond to a shape of the anatomical structure and can extend almost all of the way around the anatomical structure, for example at least around 270° of a circle, thus assisting a user in passing the suture around the anatomical structure without having to manually manipulate the suture delivery device at awkward angles around adjacent tissue.

FIELD

The present disclosure relates generally to methods and devices forpassing sutures around anatomical structures.

BACKGROUND

The complete or partial detachment of ligaments, tendons and/or othersoft tissues from their associated bones within the body are commonplaceinjuries, particularly among athletes. Such injuries generally resultfrom excessive stresses being placed on these tissues. By way ofexample, tissue detachment may occur as the result of an accident suchas a fall, over-exertion during a work-related activity, or during thecourse of an athletic event. In the case of a partial detachment, theinjury will frequently heal itself, if given sufficient time and if careis taken not to expose the injury to further undue stress. In the caseof complete detachment, however, surgery is often needed to re-attachthe soft tissue to its associated bone.

Conventional surgical procedures for repairing soft tissue detachment,e.g., ligament detachment, can employ a ligament graft to replace one ormore torn ligaments. If a ligament graft is used, it can be attached toa bone using one or more sutures, which therefore must be passed aroundthe bone to attach the ligament thereto. Passing the one or more suturesaround the bone can be a time-consuming and difficult portion of thesurgery, since conventional tools for passing suture around bone requirethe surgeon to approach the bone at an awkward angle and are often notcustomized for use with complex anatomies. Manipulating around complexanatomical structures can be even more difficult in minimally invasivesurgery. In conventional minimally invasive procedures, surgical toolsmust be inserted through one or more small incisions, thus limitingvisibility of the surgical site and a surgeon's ability to manipulatethe surgical tools at varying angles.

For example, one common injury is acromioclavicular (“AC”) separation,in which one or more ligaments connecting the clavicle to the scapulaare torn, typically by blunt force trauma. FIG. 1A shows a healthy ACjoint 10, with a coraco acromial ligament 12, an acromio clavicularligament 14, and coraco clavicular ligaments 16, 18 intact. As shown,each of the ligaments 12, 14, 16, 18 connect a clavicle 20 to a scapula24, in particular to a coracoid process 22. FIG. 1B shows a grade IIItorn AC joint 10′ having undergone AC separation, in which an acromioclavicular ligament 14′ and coraco clavicular ligaments 16′, 18′ havebeen torn, thus partially severing the connection of a clavicle 20′ to ascapula 24′. This condition can result in severe pain, swelling, andbruising.

Severe AC separations, such as the grade III separation shown in FIG.1B, can be repaired surgically using an anatomical coracoclavicularrepair (“ACCR”) technique. Conventional ACCR methods can employ aligament graft and at least one suture affixed thereto to reattach theclavicle 20′ to the scapula 24′. To fix the ligament graft to thescapula 24′, a surgeon must typically wrap the ligament graft around thecoracoid process 22′ by first manipulating the suture around thecoracoid process 22′. However, conventional tools for passing the suturearound the coracoid process 22′ can require a surgeon to manuallymanipulate the suture around the coracoid process 22′, which can involvemanipulating a rigid tool at awkward angles in tight spaces. This canlead to an increased risk of tissue damage and can increase surgicaltime.

Accordingly, there remains a need for improved methods and devices forpassing sutures around anatomical structures.

SUMMARY

The present invention generally provides methods and devices for passingsutures around anatomical structures. In one aspect, a suture deliverydevice is provided that has a body portion with a lumen formed thereinand extending along at least a portion of a longitudinal axis thereof,an actuation member operatively associated with the body portion, and asuture delivery member that can have a suture retaining feature thereon.The suture delivery member can be deployable from a distal end of thebody portion and can be selectively movable by the actuation member froma retracted configuration to an advanced configuration. The suturedelivery member can also have a distal end that is pre-shaped in an arcthat defines at least about 270° of a circle, about 270° to about 310°of a circle, or about 310° of a circle.

The body of the suture delivery device can include a proximal handle anda distal shaft. The distal shaft can have a lumen extending therethroughand can have a distal end that is curved. In one aspect, the lumen canextend through an entire length of the body portion, and/or the suturecan extend through the lumen.

The suture delivery member can be formed in a variety of ways. In oneaspect, the suture delivery member can be formed from a shape memorymaterial. The shape memory material can be one of acopper-zinc-aluminum-nickel alloy, a copper-aluminum-nickel alloy, and anickel titanium alloy. The suture delivery member can have a sutureretaining feature formed on a distal end thereof, which can be a notch.

In one embodiment, the actuation member can be a plunger. The plungercan include a depth indication feature for measuring a length of thesuture delivery member extending beyond the distal end of the bodyportion. Additionally or alternatively, the plunger can include adirection indication feature that indicates a direction of curvature ofthe arc of the suture delivery member. Similarly, the handle can includea direction indication feature that indicates a direction of curvatureof the arc.

In another aspect, a method for passing a suture around an anatomicalstructure is provided that includes inserting a suture delivery deviceinto a body of a patient such that a distal end of a the suture deliverydevice is positioned adjacent to a bony structure, advancing a suturedelivery member carrying a suture from within the suture delivery devicesuch that the suture delivery member follows an arc defining at leastabout 270° of a circle to extend around the bony structure, manipulatingthe suture to engage the bony structure, and passing the suture througha soft tissue. The method can further include, after manipulating thesuture to engage the bone, releasing the suture from the suture deliverydevice. Additionally or alternatively, the method can further includeattaching the suture to a ligament graft and securing the ligament graftto the bone using the suture. The hone can comprise the coracoid processand/or the ligament graft can be used to repair a torn acromioclavicularjoint.

BRIEF DESCRIPTION OF DRAWINGS

This invention will be more fully understood from the following detaileddescription taken in conjunction with the accompanying drawings, inwhich:

FIG. 1A (PRIOR ART) is a perspective view of a healthy AC joint;

FIG. 1B (PRIOR ART) is a perspective view of a torn AC joint havingundergone AC separation;

FIG. 2 is a side view of one embodiment of a suture delivery device;

FIG. 3 is an exploded view of the suture delivery device of FIG. 2;

FIG. 4 is a side view of a handle of the suture delivery device of FIG.2;

FIG. 5 is a proximal end view of the handle of FIG. 4;

FIG. 6 is a distal end view of the handle of FIG. 4;

FIG. 7 is a perspective view of a shaft of the suture delivery device ofFIG. 2;

FIG. 8 is a partial side view of a suture delivery member of the suturedelivery device of FIG. 2;

FIG. 8A is a perspective view of another embodiment of a suture deliverymember;

FIG. 9 is a side view of an actuation member of the suture deliverydevice of FIG. 2;

FIG. 10 is a distal end view of the actuation member of FIG. 2;

FIG. 11 is a perspective view of a step of a method for performing ACCRin which the suture delivery device of FIG. 2 is inserted into the tornAC joint of FIG. 1B;

FIG. 12 is a perspective view of a step of the method for performingACCR in Which the suture delivery member of FIG. 8 is at least partiallydeployed from the suture delivery device of FIG. 2;

FIG. 13 is a perspective view of a step of the method for performingACCR in which a suture grasper is used to pull a suture deployed fromthe suture delivery device of FIG. 2;

FIG. 14 is a perspective view of a step of the method for performingACCR in which a ligament graft having a suture attached thereto isinserted into the body;

FIG. 15 is a perspective view of a step of the method for performingACCR in which the ligament graft of FIG. 14 is pulled through holes in abone; and

FIG. 16 is a perspective view of a step of the method for performingACCR in which the ligament graft of FIG. 15 is secured to the bone.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the methods and devices disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those skilled in the art will understand that the methods anddevices specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the present invention is defined solely by the claims. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the present invention.

Further, in the present disclosure, like-numbered components of theembodiments generally have similar features, and thus within aparticular embodiment each feature of each like-numbered component isnot necessarily fully elaborated upon. Additionally, to the extent thatlinear or circular dimensions are used in the description of thedisclosed systems, devices, and methods, such dimensions are notintended to limit the types of shapes that can be used in conjunctionwith such systems, devices, and methods. A person skilled in the artwill recognize that an equivalent to such linear and circular dimensionscan easily be determined for any geometric shape. Sizes and shapes ofthe systems and devices, and the components thereof, can depend at leaston the anatomy of the subject in which the systems and devices will beused, the size and shape of components with which the systems anddevices will be used, and the methods and procedures in which thesystems and devices will be used.

Various exemplary methods and devices are provided for passing suturesaround anatomical structures. In an exemplary embodiment, shown in FIG.2, a suture delivery device 100 is provided that includes a body portion102 having a suture delivery member 104 disposed therein and configuredto pass a suture 106 (FIG. 3) around an anatomical structure. Uponactuation of an actuation member 108 disposed on the body portion 102,the suture delivery member 104 can be moved between a retractedconfiguration (FIG. 11) in which the suture delivery member 104 isdisposed within the body 102 and an advanced configuration (FIGS. 2 and12) in which the suture delivery member 104 extends distally beyond thebody 102. In the advanced configuration, at least a distal portion 110of the suture delivery member 104 can be preconfigured to assume anarcurate shape that facilitates passage of the suture 106, which may beattached thereto, around the anatomical structure. The curvature of thearcurate shape can correspond to a curvature of the anatomical structureand can extend almost all of the way around the anatomical structure,for example at least around 270° of a circle. The arcurate shape of thedistal portion 110 can thus assist a user in locating the anatomicalstructure and in passing the suture 106 around the anatomical structurewithout having to manually manipulate the suture delivery device 100 atawkward angles around adjacent soft and/or bony tissue, thus reducingsurgical time and a risk of injury to the adjacent tissue.

The body portion 102 can be of any shape and size to facilitate grippingof a proximal portion of the suture delivery device 100 and insertion ofat least a distal portion of the suture delivery device 100 into a bodyof a patient. In an exemplary embodiment, shown in FIGS. 2-4, the bodyportion 102 can include a handle 112 for gripping and a shaft 114extending distally therefrom for insertion into the patient's body.Although the handle 112 and the shaft 114 are shown to be elongate andaligned along a longitudinal axis L in the illustrated embodiment, itwill be appreciated by a person skilled in the art that any portion ofthe body 102 can be offset from any one or more portions to facilitatemanipulation of the suture delivery device 100 around anatomicalstructures. By way of non-limiting example, a longitudinal axis of thehandle 112 can be offset from a longitudinal axis of the Shaft 114. Alsoto facilitate manipulation of the suture delivery device 100 aroundanatomical structures, in particular around soft tissue, one or moreedges of the body portion 102 can be chamfered. The chamfered edges canreduce a risk of damage to surrounding tissue as the suture 106 isdelivered to a desired anatomical site and can also facilitatecomfortable gripping of the suture delivery device 100 by the user.

With reference to FIGS. 2-4, the handle 112 can be a generally elongatemember having a proximal portion 121 and a distal portion 122. Thehandle 112 can be configured in a variety of ways to improve the user'sability to deliver and/or position the suture 106 around the anatomicalstructure. For example, the handle 112 can have various features thereonto facilitate gripping, at least along the proximal portion 121 thereof,and/or can be formed from one or more materials that facilitategripping. In an exemplary embodiment, shown in FIG. 4, the handle 112can have multiple ridges, each separated by a valley. Although anynumber of ridges and valleys can be used, one can utilize from one toabout five ridges. In an exemplary embodiment, four ridges 118 a, 118 b,118 c, and 118 d are separated by four valleys 120 a, 120 b, 120 c, 120d formed therebetween. Each of the valleys 120 a, 120 b, 120 c, 120 dcan be configured for gripping by one or more fingers of the user. Eachof the ridges 118 a, 118 b, 118 c, and 118 d can extend radially outwardfrom the longitudinal axis L and any circumferential length around thehandle 112, although in an exemplary embodiment the ridges 118 a, 118 b,118 c, and 118 d extend around an entire circumferential length of thehandle 112. One skilled in the art will appreciate that there can be anynumber of ridges and valleys spaced at any distance apart from oneanother sufficient to accommodate one or more figures of a user withineach of the valleys 120 a, 120 b, 120 c, 120 d. Any combination of theridges 118 a, 118 b, 118 c, and 118 d and the valleys 120 a, 120 b, 120c, 120 d, e.g., the ridge 118 a and the valley 120 a, can form aseparable unit that is removably attachable to the remaining portion ofthe handle 112, e.g., by screwing, snap-fit, or any other attachmentmeans, to allow the user to adjust a length of the handle 112 based on,e.g., a desired depth of insertion of the suture delivery device 100and/or a size of the user's hand. Alternatively, as in the illustratedembodiment, the handle 112 can be an integrally formed unit.

To further facilitate suture delivery, a portion of the suture deliverydevice 100, such as the distal portion 122 of the handle 112, can haveat least one direction indication feature formed thereon that providesinformation about an orientation of the distal portion of the suturedelivery device 100 to the user, which can be useful when the distalportion of the suture delivery device 100 is inserted through anincision into the patient's body and is not visible to the user. In theillustrated embodiment, an arrow 138 etched along a distal portion 122of the handle 112 can indicate a direction of curvature of the suturedelivery member 104 when in the advanced configuration. Thus, the usercan know the direction of the suture delivery member 104 within thepatient's body without being able to see the suture delivery member 104.This feature can be particularly useful for minimally invasive surgicalprocedures, in which the suture delivery device 100 is inserted througha portal to minimize trauma incurred by the surgery. It will beappreciated by a person skilled in the art that the direction indicationfeature could be any etching or marking on an exterior surface of theproximal portion of the suture delivery device 100 and can indicate anytype of information about the distal portion of the instrument 100 thatis configured for insertion into the body.

As noted above, the handle 112 can be generally elongate, but it canhave any shape suitable to its intended use. In one embodiment, shown inFIG. 4, the distal portion 122 of the handle 112 is tapered tofacilitate improved visibility and/or to make it possible for a portionof the handle 112 to be inserted into a portal or an incision in thepatient's body. The degree of tapering can vary, but in the illustratedembodiment the distal portion 122 tapers such that a distal-facing will124 of the handle 112 has a diameter D_(H2) that is smaller than adiameter D_(H1) of a proximal-facing wall 126 of the handle 112.Furthermore, as mentioned above, various edges of the handle 112 can bechamfered to facilitate both safe insertion into the patient's body andcomfortable gripping by the user. For example, the proximal-facing wall126 of the handle 112, shown in FIG. 5, can have an outer chamfered edge128 and an inner chamfered edge 130, and the distal-facing wall 124,shown in FIG. 6, can have an outer chamfered edge 132 and an innerchamfered edge 134.

The handle 112 can have any length suitable for gripping and handling,as will be appreciated by a person skilled in the art. Generally,however, the length of the handle 112 can be in the range of about 3inches to 6 inches and a cross-sectional dimension of the handle 112 canbe in the range of about 0.5 inches to 2 inches.

As noted above, the body portion 102 further includes a shaft 114 thatextends distally from the handle 112. The shaft 114 can be configured ina variety of ways such that it is suitable for insertion into a body ofa patient. In the illustrated embodiment, shown in FIGS. 2, 3, and 7,the shaft 114 is a generally elongate tube having a substantiallyuniform, circular cross-section with an outer diameter D_(SO) along anentire length thereof although it will be appreciated by a personskilled in the art that the shaft 114 can have any cross-sectional shapeand size, either constant or varying, along any length thereof. Theouter diameter D_(SO) and a length of the shaft 114 can be of any sizesuitable for insertion into the patient's body, although generally thediameter D_(SO) can be in the range of about 2 mm to 8 mm and the lengthof the shaft 114 can be in the range of about 3 inches to 8 inches. Theshaft 114 can be made of any one or more materials suitable forinsertion in the patient's body, e.g., stainless steel. In someembodiments, a distal portion 148 of the shaft 114 can be formed from amore flexible material than a proximal portion 146 of the shaft 112 tohelp the user manipulate the shaft 114 around delicate anatomicalstructures effectively but with a reduced risk of damage. Also,similarly to the handle 112, the shaft 114 can have chamfered edges toreduce a risk of harm to surrounding tissue during insertion into thepatient's body.

The shaft 114 can have one or more features thereon to assist a surgeonin locating a desired anatomical structure and/or in stabilizing thesuture delivery device 100 against the desired anatomical structure. Forexample, the distal portion 148 of the shaft 114 can be curved or angledwith respect to the longitudinal axis L. A radius of curvature of thedistal portion 148 can vary. By way of non-limiting example, the radiusof curvature of the distal portion 148 can be about 0.5 inches.

As explained below, a passageway can extend through any length of thebody portion 102 for seating the suture 106 and various elementstherein. By way of non-limiting example, the passageway can extendthrough both the handle 112 and the shaft 114, from a proximal-most endof the handle 112 to a distal-most end of the shaft 114, to form acontinuous passageway through the body 102. The passageway can have anycross-sectional shape and any size, either constant or varying along alongitudinal length thereof, sufficient to accommodate one or more ofthe actuation member 108, the suture delivery member 104, and the suture106 therein. In an exemplary embodiment, the passageway has a generallycircular cross-section along an entire length thereof with a firstdiameter along a proximal portion that is large enough to accommodatethe actuation member 108 and a second diameter along the distal portionthat is smaller than the first diameter, but large enough to accommodatethe suture delivery member 104 therein, in addition, the first andsecond diameters of the passageway can be large enough to slidably seatthe suture 106 through arty length thereof, either adjacent to or withinthe actuation member 108 and/or the suture delivery member 104.

With reference to FIGS. 3-7, the passageway can extend through more thanone element of the suture delivery device 100 and can be formed fromvarious discrete channels. In the illustrated embodiment, a proximalportion of the passageway runs through a channel 136 of the handle 112and a distal portion of the passageway runs through a channel 140 of theshaft 114. The channel 136 can have any cross-sectional shape and anysize, although in the illustrated embodiment the channel 136 has agenerally circular cross-sectional shape and is configured for seatingthe actuation member 108 in a proximal portion thereof and the shaft 114in a distal portion thereof. Accordingly, a diameter of the channel 136decreases from a proximal end of the channel 136 to a distal end of thechannel 136, either constantly or in a step-wise manner, such that theproximal end of the channel 136 is configured to seat at least a portionof the actuation member 108 and the distal end of the channel 136 isconfigured to seat at least a portion of the shaft 14. Accordingly, adiameter D_(HP) of the proximal opening 142 of the channel 136 can belarger than a diameter D_(HD) of the distal opening 144 of the channel136. In particular, the diameter D_(HP) of the proximal opening 142 canbe larger than a diameter of at least a distal portion of the actuationmember 108 and the diameter D_(HD) of the distal opening 144 can belarger than the outer diameter D_(SO) the shaft 114.

In the illustrated embodiment, the channel 136 forms a continuouspassageway from the proximal-most end of the handle 112 to a distal-mostend of the handle 112, although it will be appreciated by a personskilled in the art that the channel 136 can extend through any portionof the handle 112. In an alternative embodiment, not shown, the handle112 can have multiple channels for seating different features, e.g., achannel for seating the actuation member 108 and a channel for seatingthe shaft 114.

The channel 136 of the handle 112 can be configured to mate with theshaft 114 and the actuation member 108 in a variety of ways. In anexemplary embodiment, the diameter D_(SO) of the shaft 114 and thediameter D_(HD) of the distal opening 144 of the channel 136 can besized to allow for compression or interference fit of the shaft 114 tothe handle 112, thus preventing relative movement between the shaft 114and the handle 112. Although in some embodiments the shaft 114 canrotate or slide relative to the handle 112, for example to adjust anorientation or a length of the suture delivery device 100, in theillustrated embodiment a fit between the shaft 114 and the handle 112prohibits any movement of the shaft 114 with respect to the handle 112.In an alternative embodiment, the shaft 114 can be constructed so as tobe unitary or integral with the handle 112.

By contrast, the channel 136 can be configured to mate with theactuation member 108 such that the actuation member 108 is slidablewithin the channel 136 but can be prohibited from rotation within thehandle 112. In the exemplary embodiment, as shown in FIG. 5, theactuation member 108 is prevented from rotating within the handle 112 byfirst and second ridges 150 a, 150 h that extend radially inward from aninner wall 137 of the handle 112 and are configured to engage first andsecond notches 152 a, 152 b of the actuation member 108. Although thereare two, generally rectangular ridges 150 a, 150 b in the illustratedembodiment, there can be any number of ridges of any shape and size,same or different from one another. The ridges 150 a, 150 b can have anylongitudinal length suitable for engagement with the actuation member108, for example the ridges 150 a, 150 b can be formed only along aproximal portion of the channel 136. The handle 112 can also have a stopmechanism (not shown), for example a protrusion extending radiallyinward from the inner wall 137 of the handle 112 along a proximalportion thereof to prevent the actuation member 108 from falling out ofthe handle 112. In another embodiment, the relative proportions of theridges 150 a, 150 b and the notches 152 a, 152 b can change alongproximal-most ends thereof to create a tighter fit between the ridges150 a, 150 b and the notches 152 a, 152 b that prevents further proximalmovement. By way of non-limiting example, the proximal-most ends of theridges 150 a, 150 b can extend radially inward to a depth that isgreater than a depth of the proximal-most ends of the notches 152 a, 152b, thus preventing proximal movement of the actuation member 108 beyonda desired distance. Additionally or alternatively, there can also be asecond stop mechanism along a distal end of the handle 112 to prohibitdistal movement of the actuation member 108 beyond a desired distanceinto the handle 112 and therefore a desired distance that the suturedelivery member 104 extends beyond the body portion 102.

Like the channel 136 of the handle 112, the channel 140 of the shaft 114can have any cross-sectional shape and any diameter, although in theillustrated embodiment the channel 140 has a generally circularcross-sectional shape and a constant diameter D_(SI) along an entirelength thereof. The channel 140 can form a continuous passageway from aproximal-most end of the shaft 114 to the distal-most end of the shaft114, although the channel 140 can extend along any length of the shaft114. At least a distal portion of the channel 140 can be configured toslidably seat the suture delivery member 104. In particular, thediameter D_(SI) of the channel 140 can be larger than an outer diameterD_(D) of the suture delivery member 104, at least along the distalportion of the channel 140.

The suture delivery member 104 can be configured to be slidably seatedwithin at least a portion of the channel 136 of the handle 112 and thechannel 140 of the shaft 114. As shown in FIGS. 2, 3, and 8, in anexemplary embodiment the suture delivery member 104 is a solid,generally elongate structure that can be small enough to fit within thechannel 136 and the channel 140. The suture delivery member 104 can haveany longitudinal length suitable for insertion into the patient's body.By way of non-limiting example, the diameter D_(D) of the suturedelivery member 104 can be in the range of about 0.015 inches to 0.100inches, and the length of the suture delivery member 104 can be in therange of about 4 inches to 8 inches. In the illustrated embodiment, thesuture delivery member 104 extends through both the handle 112 and theshaft 114 in both the retracted and advanced configurations.

The suture delivery member 104 can be configured to engage one or moresutures in a variety of ways. In the illustrated embodiment, the suturedelivery member 104 has a suture engaging notch 154 formed on a distalportion 110 thereof. Because the notch 154 of the illustrated embodimentis formed on a distal tip of the distal portion 110, the suture 106 canbe passed around an anatomical structure substantially as far as thesuture delivery member 104 extends around the anatomical structure inthe advanced configuration. The notch 154 can be configured to engagethe suture 106 directly and/or it can be configured to engage acorresponding engagement feature of the suture 106. Accordingly, thenotch 154 can have a width W_(N) and a depth D_(N) suitable for wrappingof the suture 106 therearound at least one time, and/or for mating withthe corresponding engagement feature of the suture 106. By way ofnon-limiting example, the corresponding engagement feature of the suture106 can a needle (not shown) through which the suture 106 is threadedand which is configured to engage the notch 154 by, e.g., snap-fit,compression fit, etc. The notch 154 can grasp the suture 106 along anyportion thereof, for example along a central portion thereof, such thatat least the central portion of the suture 106 is retracted inside thechannel 140 of the shaft 114 when the suture delivery member 104 is inthe retracted position. One or more trailing ends of the suture 106 canextend through the channels 140, 136 adjacent to the suture deliverymember 104. In another embodiment, shown in FIG. 8A, the suture deliverymember 104 can have a lumen 155 formed through any length thereof toallow for threading of the suture 106 through the lumen 155.Additionally or alternatively, the suture delivery member 104 can have alongitudinal groove 157 formed through any length of an exteriorsidewall thereof. The lumen 155 and/or the groove 157 can each have asize sufficient to slidably seat one or more sutures extendinglongitudinally therethrough.

As mentioned above, the suture delivery member 104 extends through thebody portion 102 and can be configured to move between the retractedconfiguration and the advanced configuration as a result of attachmentto the actuation member 108. In the illustrated embodiment, the suturedelivery member 104 slides along the longitudinal axis L to moveproximally to the retracted configuration and distally to the advancedconfiguration. In the retracted configuration, an entire length, orsubstantially the entire length, of the suture delivery member 104 canbe enclosed within the channel 136 and the channel 140. The suturedelivery member 104 can be disposed in the retracted configurationduring insertion into the patient's body, thus protecting the suturedelivery member 104 from exposure to tissue. In the advancedconfiguration, at least the distal portion 110 of the suture deliverymember 104 can extend distally beyond a distal-most end of the bodyportion 102 to deliver the suture 106, which can be attached thereto,around an adjacent anatomical structure. Between the retracted andadvanced configurations, the suture delivery member 104 can assume oneof many intermediate configurations in which the distal portion 110 ofthe suture delivery member 104 extends any distance beyond thedistal-most end of the body portion 102 that is shorter than a distancethat the suture delivery member 104 extends beyond the distal-most endof the body portion 102 in the advanced configuration.

In the advanced configuration, at least the distal portion 110 of thesuture delivery member 104 can be preconfigured to an arcurate shapesuitable for passing the suture 106 around an anatomical structure. Thatis, the distal portion 110 is biased to an arcurate shape. Inner wallsof the shaft 114 constrain the distal portion 110 in the retractedconfiguration, causing the distal portion 110 to be substantiallystraight. However, when advanced beyond the shaft 114, the distal end110 is free to assume its arcurate shape. An arc α defined by the distalportion 110 in the advanced configuration can extend around less than360° of a circle, for example around about 270° of a circle or betweenabout 270° of a circle and about 310° of a circle. This can allow a userto pass the suture 106, which can be attached to the suture deliverymember 104, almost all the way around the anatomical structure simply bydeploying the suture delivery member 104 to the advanced configurationwhen it is positioned adjacent to the anatomical structure. That the area does not form a closed circle in the advanced configuration, or in anyintermediate configuration, can facilitate grasping of the suture 106from the suture delivery member 104 once the suture delivery member 104has been deployed by reducing a risk of the suture 106 catching on aproximal portion 111 of the suture delivery member 104 and leaving a gapbetween adjacent portions of the suture delivery member 104 to allow forinsertion of a grasping tool. A radius R_(A) of the arc α can besubstantially the same as a radius of the anatomical structure, suchthat the suture delivery member 104 is customized for use with aparticular anatomical structure and can pass closely around theanatomical structure without running into nearby anatomical structuresor tissue. Moreover, although the arc α of the illustrated embodiment issubstantially circular, the arc α can assume any shape to follow thecurvature of the anatomical structure as closely as possible, which canoptimize the suture delivery device 100 for use particularly in complexanatomies where the user is operating in tight spaces.

The arc α of the suture delivery member 104 can be configured to extendin any direction. As is clear from FIG. 3, a direction of curvature ofthe arc α can be the same as a direction of curvature of the distalportion 140 of the shaft 114, such that the arc α merely completes theportion of the circle formed by the distal portion 140 of the shaft 114.In this way, the shaft 114 can help to direct the direction of curvatureof the suture delivery member 104 in the advanced configuration. Asmentioned above, the direction of the arc α can be indicated by one ormore direction indication features, for example the arrow 138 on thehandle 112. Specifically, in the illustrated embodiment, the arc αcurves back towards a sidewall on which the arrow 138 is etched.

The distal portion 110 of the suture delivery member 104 can beconfigured to assume the arcurate shape in a variety of ways. In someembodiments, the suture delivery member 104 can be formed from a shapememory material, which can include a single material or any combinationof materials, such that at least the distal portion 110 of the suturedelivery member 104 is curved in the arcurate shape when in a restingconfiguration. Non-limiting examples of shape memory materials includecopper-zinc-aluminum-nickel alloys, copper-aluminum-nickel alloys,nickel-titanium alloys such as Nitinol, thermoplastic materials such asNylon or Nylon blends, and shape memory polymers such as Verifiex™. Theshape memory material can facilitate the suture delivery member 104being biased to the arcurate shape. The shape memory material canfacilitate advancement of the suture delivery member 104 into tissue byallowing the suture delivery member 104 to be deformed or bent in theretracted configuration in which the suture delivery member 104 has asmaller width than a width thereof in the advanced configuration, whilealso allowing the suture delivery member 104 to automatically move fromthe retracted configuration to the advanced configuration. In anexemplary embodiment, the entirety of the suture delivery member 104 canbe formed from one or more shape memory materials. In another exemplaryembodiment, only the distal portion 110 of the suture delivery member104 can be formed from one or more shape memory materials, and anotherportion of the suture delivery member 104, e.g., an intermediate portionfrom which the distal portion extends, can be formed of a non-shapememory material, e.g., titanium, stainless steel, etc.

The actuation member 108 can be any type of actuation member configuredfor manual actuation that functions to move the suture delivery member104 between the advanced and retracted configurations. The actuationmember 108 can be disposed on the proximal portion of the suturedelivery device 100, which can facilitate handling of the actuationmember 108 outside the patient's body. By way of non-limiting example,the actuation member 108 can be a button, a switch, a slider, a knob,etc., although in the illustrated embodiment the actuation member 108 isa plunger slidably disposed within the handle 112. As shown in FIGS. 3and 9, the actuation member 108 is a generally elongate member with ascircular cross-section, but the actuation member 108 can be of any shapesuitable for manual actuation. The actuation member 108 can be formedfrom a material configured to facilitate gripping by the user, and/orcan have one or more features configured to facilitate gripping. In theillustrated embodiment, the actuation member 108 has a flange 156 on aproximal portion thereof to help the user advance and retract theactuation member 108. The flange 156 can also serve as a stop to preventdistal movement of the actuation member 108 beyond a desired point. Forexample, the flange 156 can abut the proximal-most end of the handle 112when the suture delivery member 104 is in the advanced configuration.

The actuation member 108 can be configured to move the suture deliverymember 104 between the advanced and retracted configurations in avariety of ways. In the illustrated embodiment, the user can advance thesuture delivery member 104 to the advanced configuration by sliding theactuation member 108 distally, and can retract the suture deliverymember 104 to the retracted configuration by sliding the actuationmember 108 proximally. Because the actuation member 108 is directlyattached to the suture delivery member 104 in the illustratedembodiment, movement of the actuation member 108 directly corresponds tomovement of the suture delivery member 104. In particular, the actuationmember 108 can have a bore 162 suspended within a channel 164 of theactuation member 108. As shown in FIG. 10, the bore 162 is supportedwithin the channel 164 by support members 166 extending radially inwardfrom an inner wall of the channel 164. The bore 162 can be sized tofixedly secure any length of a distal portion of the suture deliverymember 104 therein, either permanently or detachably, for example byinterference fit, friction fit, snap fit, etc. Although the bore 162 ofthe exemplary embodiment forms a separate passageway within the channel164, it will be appreciated by a person skilled in the art that the bore162 and the support members 166 can be eliminated, and the channel 164can be configured to directly attach to the suture delivery member 104.It will further be appreciated by a person skilled in the art that therecan be any number of intervening elements between the suture deliverymember 104 and the actuation member 108, for example a mechanism toincrease or decrease three applied to the actuation member 108 andtransferred to the suture delivery member 104, or to convert one type ofmovement of the actuation member 108 to a different type of movement ofthe suture delivery member 104.

As explained above, the actuation member 108 can have one or morefeatures thereon for mating engagement with the handle 112. In theexemplary embodiment, the notches 152 a, 152 b are formed on oppositesides of the actuation member 108 for mating with the ridges 150 a, 150b of the handle 112. The notches 152 a, 152 b can be of any shape,number, and size effective for mating engagement with the ridges 150 a,150 b and to allow for sliding of the actuation member 108 with respectto the handle 112. In some embodiments, the notches can have one or morefeatures thereon and/or can be formed from a material that createsfriction between the actuation member 108 and the handle 112. This canhelp prevent the user from accidentally moving the suture deliverymember 104 between the advanced and retracted configurations duringsurgery.

Various features can be formed on the actuation member 108 to indicatecertain information to the user about the distal portion of the suturedelivery device 100. For example, similar to the arrow 138 of the handle112 described above, the actuation member 108 can have a directionindication feature, e.g., arrow 160 etched on a proximal portionthereof. The arrow 160 can indicate the direction of curvature of thesuture delivery member 104 when in the advanced configuration. Inparticular, the arrow 160 of the actuation member 108 can be visible tothe user even where the distal portion 122 of the handle 112 is insertedinto the patient's body and is therefore not visible to the user. Theactuation member 108 can additionally or alternatively have at least onedepth indication feature, for example demarcation lines 158, which canindicate a distance that the suture delivery member 104 extends beyondthe distal-most end of the shaft 114. For example, a number ofdemarcation lines 158 extending proximally beyond the proximal-most endof the handle 112 can indicate a certain distance that the suturedelivery member 104 extends distally beyond the distal-most end of theshaft 114.

The actuation member 108 can have any length suitable for manualactuation, as will be appreciated by a person skilled in the art.Generally, however, the length of the actuation member 108 can be in therange of about 3 inches to 6 inches and a cross-sectional dimension ofthe actuation member 108 can be in the range of about 0.5 inches to 1inch.

The suture delivery device 100 can include one or more lockingmechanisms to lock the suture delivery member 104 in the advancedconfiguration, the retracted configuration, or in any intermediateconfiguration between the retracted and advanced configurations. Thelocking mechanism can be coupled to the proximal portion of the suturedelivery device 100 and can include an actuator, e.g., a button, a knob,a switch, etc., configured to be manually manipulated by the user. Inanother embodiment, the locking mechanism can include prongs or notchesspaced at intervals on the inner wall 137 of the handle 112 or along theactuation member 108, which can correspond to the other of a prong or anotch formed on the other of the inner wall 137 or the actuation member108, thus functioning as a ratcheting mechanism to hold the suturedelivery member 104 in place along various phases ofadvancement/retraction. For example, one or more of the demarcationlines 158 on the actuation member 108 can be notches that correspond toa circular protrusion formed on the inner wall 137 of the handle 112. Inthis embodiment, the user must apply a tensional force exceeding athreshold force to the actuation member 108 to disengage the notchesfrom the corresponding prong to the next phase ofadvancement/retraction. The locking mechanism, by allowing for lockingof the suture delivery member 104 in the intermediate configuration, canallow for the user to select a desired length of the suture deliverymember 104 extending beyond the distal end of the body portion 102,thereby allowing the suture delivery device 100 to be effective in smallsurgical spaces and/or in crowded surgical spaces.

The suture delivery device 100 can be configured for use with varioustypes and sizes of sutures in several ways. For example, the suture 106can be a number 2 suture and can be of any length suitable for engagingbone and/or tissue. Any of the channel 136 of the handle 112, thechannel 140 of the shaft 114, a lumen and/or channel of the suturedelivery member 104, and the channel 164 of the actuation member 108 canadditionally or alternatively have one or more engagement featuresformed therein for slidably seating the suture 106 and/or securing thesuture 106 to the suture delivery device 100. In one exemplaryembodiment, not shown, notches can be formed in any of theaforementioned channels along any length thereof that are sized toslidably seat the suture 106. Additionally or alternatively, a featureformed on the exterior of the suture delivery device 100 can assist inattaching a proximal portion of the suture 106 to the suture deliverydevice 100. By way of non-limiting example, a hook can be formed on theproximal portion of the suture delivery device 100, e.g., the handle112, for wrapping the suture 106 therearound. Additionally oralternatively, the suture 106 can have one or more engagement features,e.g., a needle, for mating engagement with any portion of the suturedelivery device 100.

The suture delivery devices disclosed herein can be generally used topass sutures around anatomical structures. In an exemplary embodiment, asuture delivery device can be used to pass a suture around a bonystructure.

In use, a suture delivery device can be inserted into a body of apatient in accord with customary surgical procedures, which can includeopen surgery or minimally invasive surgery (e.g., using one or moreaccess cannulae). The suture delivery device is eventually arranged suchthat a distal end of the suture delivery device is positioned adjacentto a bony structure. During insertion, a suture delivery member disposedwithin a body portion of the suture delivery device can be in aretracted configuration, in which the suture delivery member is disposedwithin an elongate body portion of the suture delivery device. Using acurved distal end of the body portion as a guide, a surgeon can locatethe bony structure and can align the suture delivery device such thatthe curved distal end of the body portion extends partially around theboy structure and such that it is oriented in the intended direction oftravel of the suture. One or more direction indication features on thesuture delivery device can indicate a direction of curvature of thedistal end of the body portion and of suture delivery member in theadvanced configuration to assist the surgeon in aligning the suturedelivery device to extend around the bony structure. Once the bodyportion is oriented in the desired position, the suture delivery membercan be distally advanced beyond a distal end of the body portion by,e.g., actuation of an actuator, to an advanced configuration, asdescribed above, or to an intermediate configuration between theretracted and advanced configurations. The surgeon can use depthindication features on the actuation member to measure a distance thatthe suture delivery member extends beyond the distal-most end of thebody portion in the advanced configuration or in any of the intermediateconfigurations. With the suture delivery member in the advancedconfiguration, a suture attached to the suture delivery member can bepassed around the bone, in one exemplary embodiment around about atleast 270° of a circle. Once the suture is disengaged from the suturedelivery device, the suture delivery member can then be retractedproximally to the retracted configuration and the suture delivery devicecan be removed from the patient's body. Surgical repair using thedelivered suture can then proceed according to accepted surgicaltechniques.

The suture delivery device can be used, for example, in an exemplaryACCR procedure shown in FIGS. 11-16, which are simplified views of theanatomy of the AC joint with various soft tissue structures (includingskin) removed for ease of illustration. Moreover, although cannulae foruse in minimally surgical procedures are not illustrated in FIGS. 11-16(for ease of viewing), a person skilled in the art will understand thatsuch devices can be used in an ACCR procedure. FIG. 11 depicts theinsertion of the shaft 114 of the exemplary suture delivery device 100into the torn AC joint 10′, the torn AC joint 10′ having been cleared oftorn ligament tissue and having had a first hole 26 and a second hole 28drilled into the clavicle 20′. The suture delivery device 100 can beadvanced, using the curved distal portion 148 of the shaft 114 to locatethe coracoid process 22′. Once located, one or both of the arrows 138,160 can indicate to a surgeon the direction of curvature of the shaft114 and the suture delivery member 104 disposed therein, thus helpingthe surgeon to orient the shaft 114 distally of the coracoid process 22′and extending partially around the coracoid process 22′. The suturedelivery member 104 can then be deployed to the advanced configuration,or to any of the intermediate configurations, by distal advancement ofthe actuation member 108, as shown in FIG. 12, such that the suturedelivery member 104 and the suture 106 extend approximately 270° of acircle around the coracoid process 22′. The surgeon can measure adistance that the suture delivery member 104 extends beyond thedistal-most end of the shaft 114 according to the number of demarcationlines 158 that extend proximally beyond the proximal-most end of thehandle 102. A suture grasping device, e.g., forceps 168 shown in FIG.13, can then be inserted into the AC joint 10′ to grasp the suture 106and detach the suture 106 from the suture delivery member 104. Once thesuture 106 is fully detached from the suture delivery device 100, thesuture delivery member 104 can be moved to the retracted configurationby proximal retraction of the actuation member 108 and the suturedelivery device 100 can be removed from the patient's body. Next, aligament graft 170 having a second suture 172 attached thereto can beinserted into the AC joint 10′ and the second suture 172 can be threadedthrough the first hole 26. The second suture 172 can be attached to thesuture 106, e.g., using the forceps 168 to tie the suture 106 to thesecond suture 172 with a knot, as shown in FIG. 14, and the ligamentgraft 170 can then be pulled along a path defined by the suture 106 andthe second suture 172. Specifically, as shown in FIG. 15, the ligamentgraft 170 can be pulled distally through the first hole 26, loopedaround the coracoid process 22′, and then pulled proximally back throughthe second hole 28. Finally, the ligament graft 170 can be secured inplace by securing the suture 106 and the second suture 172 to theclavicle 20′ and inserting fixation devices, e.g., screws 174, 176, intothe first and second holes 26, 28, respectively. Thus oriented, as shownin FIG. 16, the ligament graft 170 can secure the clavicle 20′ to thescapula 24′, thereby functioning as a replacement for torn ligaments.

A person skilled in the art will appreciate that the present inventionhas application in conventional minimally-invasive and open surgicalinstrumentation as well application in robotic-assisted surgery.

The devices disclosed herein can also be designed to be disposed ofafter a single use, or they can be designed to be used multiple times,in either case, however, the device can be reconditioned for reuse afterat least one use. Reconditioning can include any combination of thesteps of disassembly of the device, followed by cleaning or replacementof particular pieces and subsequent reassembly. In particular, thedevice can be disassembled, and any number of the particular pieces orparts of the device can be selectively replaced or removed in anycombination. Upon cleaning and/or replacement of particular parts, thedevice can be reassembled for subsequent use either at a reconditioningfacility, or by a surgical team immediately prior to a surgicalprocedure. Those skilled in the art will appreciate that reconditioningof a device can utilize a variety of techniques for disassembly,cleaning/replacement, and reassembly. Use of such techniques, and theresulting reconditioned device, are all within the scope of the presentapplication.

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. Allpublications and references cited herein are expressly incorporatedherein by reference in their entirety.

What is claimed is:
 1. A suture delivery device, comprising: a bodyportion having a lumen formed therein that extends along at least aportion of a longitudinal axis of the body portion, the body portioncomprising a proximal handle that has a plurality of hand-grippingfeatures formed in an outer surface thereof such that a diameter of thehandle varies along a length of the handle; an actuation memberoperatively associated with the body portion such that the actuationmember is configured to be coupled proximally to the handle so as toextend proximally from the handle and to be at least partially disposedwithin the handle, wherein the actuation member is configured to bemoved proximally and distally along the longitudinal axis of the bodyportion; and a suture delivery member having a suture extending alongthe suture delivery member through the lumen in the body portion suchthat the suture extends at least partially through the handle, thesuture delivery member having a suture retaining feature configured todeliver the suture, the suture delivery member being deployable from adistal end of the body portion, the suture delivery member having adistal end that is pre-shaped in an arc that defines at least about 270°of a circle, and the suture delivery member being selectively movable bythe actuation member from a retracted configuration to an advancedconfiguration when the actuation member moves distally.
 2. The suturedelivery device of claim 1, wherein the body comprises a distal shaftextending distally from the proximal handle and having a lumen extendingtherethrough.
 3. The suture delivery device of claim 2, wherein a distalend of the shaft is curved.
 4. The suture delivery device of claim 1,wherein the lumen extends through an entire length of the body portion.5. The suture delivery device of claim 4, wherein the suture extendsthrough the lumen.
 6. The suture delivery device of claim 1, wherein thesuture delivery member is formed from a shape memory material.
 7. Thesuture delivery device of claim 6, wherein the shape memory material isone of a copper-zinc-aluminum-nickel alloy, a copper-aluminum-nickelalloy, and a nickel-titanium alloy.
 8. The suture delivery device ofclaim 1, wherein the arc of the suture delivery member defines about270° to about 310° of a circle.
 9. The suture delivery device of claim1, wherein the arc of the suture delivery member defines about 310° of acircle.
 10. The suture delivery device of claim 1, wherein the sutureretaining feature is formed on a distal end of the suture deliverymember.
 11. The suture delivery device of claim 10, wherein the sutureretaining feature is a notch.
 12. The suture delivery device of claim 1,wherein the actuation member is a plunger disposed on a proximal portionof the body portion.
 13. The suture delivery device of claim 12, whereinthe plunger includes a depth indication feature for measuring a lengthof the suture delivery member extending beyond the distal end of thebody portion.
 14. The suture delivery device of claim 12, wherein theplunger includes a direction indication feature that indicates adirection of curvature of the arc.
 15. The suture delivery device ofclaim 1, wherein the handle includes a direction indication feature thatindicates a direction of curvature of the arc.